Patents

GENERAL

Israeli law provides patent protection for inventors from all countries, for any inventions, of almost any subject matter, for a period of twenty years.
Israel is a member of the Paris Convention and the Patent Corporation Treaty. Israel is also a member of UPOV.

PATENTABLE SUBJECT MATTER

Practically, every type of scientific advance which is new, non-obvious, useful and applicable in industry may be patented. Thus, any invention, of any technical nature, is patentable, including, in addition to chemical, biotechnological, mechanical and electronic inventions, also bioengineered organisms (including plants), computer software (as “means”, e.g. algorithm for carrying out a particular task), games and toys, diagnostic methods and “second indication” pharmaceuticals.

Methods for Treatment of the Human Body

In Israel, as in Europe, methods for the therapeutic treatment of the human body are not afforded patent protection, however, "use" or "Swiss-type" claims are formally acceptable. Such claims provide a reasonable replacement for "method of treatment" claims. Such claims are also recognized for primary, secondary and any subsequent medical indications of an active ingredient. There are two acceptable kinds of such "use" claims, which should conform to the following general formats:

A compound/composition/combination X for use as a medicament for the treatment of disease/disorder Y. (This claim has a "product" meaning).

Use of a compound/composition/combination in the preparation/manufacture of a medicament for the treatment of disease/disorder Y, substantially as described in the specification. (This claim has a "process" meaning).

Diagnostic methods in humans are acceptable. Unlike Europe, methods for the therapeutic treatment of non-humans (veterinary methods) are acceptable.

Biotechnological Inventions

The protection of biotechnological inventions under Israeli law and practice is essentially parallel to the protection provided in the USA and in Europe, although formally Israeli practice requires that a number of aspects of such inventions (for example antibodies, anti-sense sequences, etc.) be excluded from a main application directed to a gene and/or a protein encoded by the gene, and if desired, be pursued in separate divisional applications.

Natural products, e.g. new genes, proteins, polysaccharides, etc., are patentable provided only that the claim does not cover the product in its natural environment.

Mutants of naturally-occurring organisms -- are afforded patent protection. Moreover, even non-mutant microorganisms which are derived from non-natural environments, for example, new strains isolated from man-made waste or pollution areas, are patentable.

It is also acceptable to claim the microorganism (natural or mutant) as the active ingredient in a composition for producing a novel product (such as antibiotics, sugars, proteins etc.) produced in the microorganism. Likewise, it is acceptable to claim the use of a microorganism in the preparation/production of the novel product.

Plants

Genetically modified, including transgenic plants are afforded patent protection provided the claims are not directed to a new variety per se -- this in view of UPOV and the Israeli Plant Breeders Rights Act which provides specific registration of new varieties. Such "plant patents" may also include such aspects as a new gene, protein, vectors, methods, etc.

Chemical Inventions

The protection of chemical inventions under Israeli practice is quite similar to that in Europe, USA and most other industrialized countries. However, if an Israeli application is directed to new compounds and new intermediates to prepare such compounds, the claims for the intermediates will not be accepted in the main application. If desired, the applicant may pursue them in a separate divisional application.

EXAMINATION

Israel is a strict examining country.

The Israeli Patent Office relies on the examination results, particularly as regards prior art citations, of parallel applications in the leading examining jurisdictions (Europe, USA). In addition the Patent Office conducts an independent prior art search and examines the application on various other grounds, for example, unity of invention in the claims, sufficient support for claimed invention in the specification, etc.

Before examination, an applicant is required to file at the Patent Office all information concerning prior art references, particularly those cited against the parallel applications in other jurisdictions.

An Israeli patent application is confidential until the end of its examination. If accepted, the acceptance of the application is then published in the Official Gazette, at which time the entire examination file is opened to the public. Following publication there is a 3-month non-extendable opposition period, only after which will the application proceed to grant.

There are no provisions for deferred examinations.

Examination is automatic; no formal request for examination is required, although in special circumstances (e.g. pending infringement or substantial investment in connection with the invention in Israel) it is possible to petition for an expedited examination.

Modified Examination

An applicant may opt to have the application based on a corresponding granted patent in one of several specified examining countries, i.e. USA, Europe, New Zealand, Canada, Japan and Russia.

The claims of the Israeli application must be rendered identical to the granted claims of the foreign patent on which it is based. In such case, the application shall be deemed to have complied with the requirements of novelty, inventive step, enablement and that the claims reasonably arise out of the subject described in the specification.

The period of such examination is much shorter than the regular one. This because the invention is presumed to be novel and inventive in view of the granted foreign patent. As such, the examination concerns more formal issues specific to Israeli patent law, regulations and practice, for example, whether the claims of the corresponding patent are directed to material not patentable in Israel (e.g. methods for therapeutic treatment of humans, plant varieties, microorganisms derived directly from nature). The examiner also conducts a search to determine whether there exist pending Israeli applications which may have prior rights to the invention.

Examination of national phase PCT applications may also partake of a modified examination procedure if the parent PCT application was examined under Chapter II and the International Preliminary Examination Report is favorable for at least novelty.

SCOPE OF PROTECTION: WHAT CONSTITUTES INFRINGEMENT?

The registration of a patent entitles the proprietor to exclusive use of the patented invention.

Any commercial use or use by a commercial entity constitutes infringement (production, use, offer for sale, sale or importation which is intended for production, use, offer for sale and sale).

Exceptions:

A patented invention may be exploited experimentally in order to improve the invention or to develop a new invention.

Exploitation of a patented invention before expiration in order to prepare for and obtain a regulatory approval following an amendment of the Israeli Patent Act. Exploitation of the patented invention is permitted only in relation to Israel or other countries where local laws permit such exploitation. This amendment is a result of extensive lobbying by the Israeli generic industry, following a decision of the Tel-Aviv District Court prohibiting any unauthorized exploitation of the patented invention, including experimental use. The amendments were approved despite fierce opposition from the European Union and US Government, which contended that they were in violation of TRIPS.

OPPOSITION AND REVOCATION

Israel is a pre-grant opposition country. As such, after examination, applications in final form are accepted and published in the Official Gazette for oppositions, which may be filed within three months of the publication date, non-extendable.

If no opposition is filed or if Applicant overcomes an opposition, the application will proceed to grant and will issue as a registered patent.

Following grant and up to the end of the patent term, any one may petition the Patent Office to revoke the patent. The grounds for revocation are the same as those for opposition.

PATENT TERM EXTENSION

Patent term extension (PTE) is available in Israel for a basic patent covering a pharmaceutical substance, a pharmaceutical preparation comprising the substance, a process for the manufacture of the substance or the preparation, the medical use of the substance or the preparation, or for a basic patent covering a medical device.

The petition for patent term extension must be submitted to the Israel Patent Office within 90 days (non-extendable) from the date of registration of the pharmaceutical preparation or the medical device by the Israeli Ministry of Health.

The provision of the Israeli Patents Law that governs patent term extension has been repeatedly amended over the last decade, reflecting aggressive lobbying by the Israeli generic pharmaceutical industry, and aimed at minimizing the rights of innovative pharmaceutical companies.

Amendment No. 7 (enacted in 2006) established a new method of calculating the extension period available in Israel. This mechanism links the Israeli PTE to the shortest PTE granted in a "recognized state", and essentially renders the PTE term as short as possible.

According to Amendment No. 7, an extension order would be in effect for a period equal to the shortest extension period granted for a corresponding patent in Australia, Austria, Italy, Iceland, Ireland, Belgium, Japan, Germany, Denmark, Holland, Greece, Luxembourg, Spain, Portugal, Finland, France, Norway, Sweden, Switzerland, UK and USA.

Amendment No. 11 (enacted in 2014) narrowed the list of recognized states to six: the USA and five European countries - UK, Germany, France, Italy and Spain.

An additional restriction is that the cumulative total term (of the patent and any extension granted) shall end not later than 14 years after the date of the first marketing approval in any of the six recognized states.

PARALLEL IMPORTATION OF PATENTED PRODUCTS

Under Israeli law, parallel importation of genuine goods does not constitute trademark infringement (subject to various restrictions on repackaging, relabeling etc.). However, the parallel importation of genuine patented goods constitutes patent infringement. Further, the parallel importation of pharmaceutical products may also constitute copyright infringement (e.g., if the parallel importer translates the user's leaflets without obtaining the manufacturer's authorization).

A regulatory approval by the Ministry of Health to import a registered product (or the general "permit" granted to a Recognized Institution) does not constitute a form of "compulsory license" to import and market the product despite copyright or patent protection, and the patent or copyright owner may bring legal action to enjoin the importation and marketing of the products. The Supreme Court ruled that regulatory approval and patent rights are distinct and a regulatory approval to import a pharmaceutical product does not constitute a license to infringe.

However, in another recent judgment of the Supreme Court in Israel, the question whether parallel importation constitutes patent infringement was further examined. The judge reviewed foreign and Israeli case law in this regard as well as the implications of the TRIPS agreement on this issue and came to the conclusion that it is most probable that parallel importation does not constitute patent infringement, although this was not a conclusive judgment on this question, and currently this question is left “open”. In addition, the Supreme Court held that the question whether the reliance of the health authorities on the registration dossier (of the patent holder) for the allowance of parallel importation constitutes unjust enrichment is also a matter of private law and patent holders are entitled to enforce their rights in a civil action against the parallel importers. However, it was also held that it is most likely that the reliance on the registration dossier does not constitute unfair competition as defined in section 39(1) of the TRIPS agreement. This may be detrimental to a possible cause of action of unjust enrichment against the parallel importer.

EXTENSION OF THE TERM FOR ENTERING THE NATIONAL PHASE

Although, it is recognized under the Israeli Patent Act that the terms for entering the national phase of the PCT applications (20 and 30 months) are extendable, the Israeli Patent Office is very strict in this matter. Extensions are granted only in unusual circumstances, subject to filing an affidavit.

TERRITORIAL PROTECTION (Gaza and the West Bank)

Israeli patents are valid in the territory of the state of Israel only. They are not enforceable in the West Bank and Gaza. In these territories the Palestinian Authority maintains two separate Patent and Trademark Registries. In order to obtain protection in Gaza and in the West Bank, it is necessary to file applications in both these Patent Offices. The Gaza Patent Office is normally much quicker than the West Bank Patent Office. In the ordinary scenario whereby a patent which has already been registered in Gaza is still pending in the West Bank, it is possible that Palestinian courts would enforce the pending application in the West Bank. There is hardly any substantive examination in the Patent Offices in Gaza and the West Bank.